American Health Ranitidine Tablet Recall [US]


American Health Ranitidine Tablet Recall [US]

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US FlagUS/Silver Spring: American Health Packaging, a Columbus, Ohio establishment, recalls eleven (11) lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters from the American marketplace due to suspected levels of N-Nitrosodimethylamine (“NDMA”), a probable Human Carcinogen, above the allowable limits established by the FDA and consequential risk of Cancer, all serious health hazards.

FDA: http://ht.ly/gFcQ30qnOVO

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150-mg-100-count

Additional information:
The US Food and Drug Administration (“FDA”) reports the following prescription drug products are subject to this recall:

  • AHP Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters, sold with a carton NDC designation of 60687-322-01 and an individual dose NDC of 60687-322-11, an expiration dates of 12/31/2019 with the following AHP batch/lot numbers:
    • 179516
    • 179745
    • 180712
    • 180819
    • 181403
    • 182544
    • 183155
    • 183236
    • 185739
    • 186600
    • 186702

==> No barcodes, DINs, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, American Health Packaging has recalled eleven (11) lots of Ranitidine Tablets, USP 150 mg, 100 count Unit Dose Blisters from the American marketplace due to suspected levels of N-Nitrosodimethylamine (“NDMA”), a probable human carcinogen, above the allowable limits established by the FDA and consequential risk of Cancer. This recall was initiated in response to the recall by the manufacturer (Amneal Pharmaceuticals, LLC), that included affected lots that were repackaged by American Health Packaging. You should neither administer nor consume the recalled drug products identified above.

If you believe you have purchased or have in your possession any of the recalled Ranitidine medications, please do not consume them directly nor use them as an ingredient in another preparation or treatment plan. Instead, return the drugs to the store, pharmacist or distributor where you purchased them for a full refund.

==> To see other recalls and notifications caused by contaminated, adulterated or mislabeled Ranitidine, please search for “Ranitidine” using the Search Box at the top of this page.

If you have any questions about this recall, please contact American Health Packaging toll-free at 1-800-967-5952, option 1 from 9:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday.

American Health Packaging has arranged for return of all recalled products to lnmar Pharmaceuticals Services. Anyone with an existing inventory of the product should not use them and quarantine the recalled batch/lots immediately. Pharmacy owners who are in possession of any of the affected batch/lots should contact 1-877-475-5864 to receive a return packet. Hours of operation are 9:00 AM to 5:00 PM Eastern Standard Time, Monday to Friday.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous drugs or medications, please search for “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Carcinogenic contamination, please search for “Cancer” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 12768-2020
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
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==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
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Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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E. & O. E.

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